Primary AldosteronismPhase 3NCT03398785
Adrenal Artery Ablation Treats Primary Aldosteronism
A Phase 3 study testing Endovascular chemical Ablation of Adrenal Gland in people with Primary Aldosteronism and Hypertension, run by Third Military Medical University at 1 site in China.
Trial summary
Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Primary Aldosteronism, Hypertension
- What is being tested?
- Endovascular chemical Ablation of Adrenal Gland
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 30 Jun 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary Aldosteronis diagnosed by increased Renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
- Idiopathic aldosteronism, bilateral adrenal hyperplasia, and unilateral adrenal hyperplasia with no superior secretion confirmed with adrenal CT and adrenal venous blood (AVS).
- The patients was diagnosed with aldosteronoma or unilateral adrenal hyperplasia but refused to surgical excision.
- Signed informed consent and agreed to participate in this study.
Who cannot join
- Aldosterone cancer.
- Hyperkalemia.
- Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
- Secondary hypertension except the primary aldosteronism.
- Adrenergic insufficiency.
- Heart failure with NYHA grade Ⅱ-Ⅳ grade or unstable angina, severe cardiovascular and cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and other acute cardiovascular events.
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- Acute infections, tumors and severe arrhythmias, psychiatric disorders, drugs or alcohol addicts.
- Liver dysfunction or the following history of liver disease: AST or ALT 2 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history.
- Coagulation dysfunction.
- Pregnant women or lactating women.
- Participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial.
- Any surgical or medical condition which can significantly alter the absorption, distribution, metabolism, or excretion of any study drug.
- Allergy or any contraindications for the study drugs, contrast agents and alcohol.
- Refused to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: An Open-label, Prospective, Controlled Clinical Trial on Effects and Safety of Adrenal Artery Ablation (Triple A) for Primary Aldosteronism
Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages.
The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.
Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.
- Conditions
- Primary Aldosteronism, Hypertension
- Being tested
- Endovascular chemical Ablation of Adrenal Gland
- Keywords
- Primary Aldosteronism, Hypertension, Ablation, Adrenal Gland
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular chemical Ablation of Adrenal GlandProcedure or surgery
Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol.
| Study group | Role | What they receive |
|---|---|---|
| Intevention | Experimental | Adrenal Artery Ablation Receives: Procedure: Endovascular chemical Ablation of Adrenal Gland |
| Control | No intervention | No intervention, but treated with standard anti-hypertensive drigs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 24-h average systolic blood pressure compared with the baseline
Change of 24-h average systolic blood pressure compared with the baseline at the end of the study (24 weeks) in the intervention group.
Measured: 24 weeks
Secondary outcomes (12)
Change of 24-h average systolic blood pressure between two groups
Change of 24-h average systolic blood pressure between the intervention and control group at the end of the study (24 weeks)
Measured: 24 weeks
Change of anti-hypertensive regimen between two groups
Change of number, classes, and combinations of classes of antihypertensive drugs between the intervention and control group at the end of the study (24 weeks)
Measured: 24 weeks
Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure between two groups
Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure between the intervention and control group at the end of the study (24 weeks)
Measured: 24 weeks
Change of office systolic and diastolic pressure between two groups
Change of office systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks)
Measured: 24 weeks
Change of blood electrolytes（serum potassium and natrium in mmol/L）
Change of blood electrolytes（serum potassium and natrium in mmol/L） compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Measured: 24 weeks
Change of plasma aldosterone and 24-h urine aldosterone
Change of plasma aldosterone and 24-h urine aldosterone compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Measured: 24 weeks
Change of plasma renin
Change of plasma renin compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Measured: 24 weeks
Change of plasma cortisol and 24-h urine cortisol
Change of plasma cortisol and 24-h urine cortisol compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Measured: 24 weeks
Change of liver enzymes (ALT, AST)
Change of liver enzymes (ALT, AST) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Measured: 24 weeks
Change of serum creatinine
Change of serum creatinine compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Measured: 24 weeks
Change of fasting blood glucose
Change of fasting blood glucose in mmol/L compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Measured: 24 weeks
Change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L
Change of lipids profiles (Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride) in mmol/L compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Oct 2017
- Primary completion31 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the Intervention group will be treated with endovascular chemical ablation of adrenal gland by endovascular injection of dehydrated alcohol. Patients in the Control group will be treated with conventional anti-hypertensive drugs
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398785
- Sponsor's protocol ID
- Triple A-PA
- Status last verified
- Jul 2019
- First submitted
- 24 Dec 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun F, Hong Y, Zhang H, Liu X, Zhao Z, He H, Yan Z, Zhu Z. Determination of adrenal hypersecretion in primary Aldosteronism without aldosterone-production adenomas. BMC Endocr Disord. 2021 May 31;21(1):114. doi: 10.1186/s12902-021-00770-1.
PubMed 34059026
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Prospective, Controlled Clinical Trial on Effects and Safety of Adrenal Artery Ablation (Triple A) for Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT03398785
- Acronym / sponsor ID
- Triple A-PA
- Conditions
- Primary Aldosteronism, Hypertension
- Keywords
- Primary Aldosteronism, Hypertension, Ablation, Adrenal Gland
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages.
The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.
Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in the Intervention group will be treated with endovascular chemical ablation of adrenal gland by endovascular injection of dehydrated alcohol. Patients in the Control group will be treated with conventional anti-hypertensive drugs
| Arm | Type | Receives |
|---|---|---|
| Intevention | Experimental | Procedure: Endovascular chemical Ablation of Adrenal GlandAdrenal Artery Ablation |
| Control | No intervention | –No intervention, but treated with standard anti-hypertensive drigs |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary Aldosteronis diagnosed by increased Renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
- Idiopathic aldosteronism, bilateral adrenal hyperplasia, and unilateral adrenal hyperplasia with no superior secretion confirmed with adrenal CT and adrenal venous blood (AVS).
- The patients was diagnosed with aldosteronoma or unilateral adrenal hyperplasia but refused to surgical excision.
- Signed informed consent and agreed to participate in this study.
Key exclusion criteria (14 listed)
- Aldosterone cancer.
- Hyperkalemia.
- Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
- Secondary hypertension except the primary aldosteronism.
- Adrenergic insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular chemical Ablation of Adrenal GlandPatients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol. | Procedure or surgery | Intevention |
Primary outcome
Change of 24-h average systolic blood pressure compared with the baseline
Time frame: 24 weeks
Change of 24-h average systolic blood pressure compared with the baseline at the end of the study (24 weeks) in the intervention group.
12 secondary outcomes
Change of 24-h average systolic blood pressure between two groups
Time frame: 24 weeks
Change of anti-hypertensive regimen between two groups
Time frame: 24 weeks
Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure between two groups
Time frame: 24 weeks
Change of office systolic and diastolic pressure between two groups
Time frame: 24 weeks
Change of blood electrolytes（serum potassium and natrium in mmol/L）
Time frame: 24 weeks
Change of plasma aldosterone and 24-h urine aldosterone
Time frame: 24 weeks
Change of plasma renin
Time frame: 24 weeks
Change of plasma cortisol and 24-h urine cortisol
Time frame: 24 weeks
Change of liver enzymes (ALT, AST)
Time frame: 24 weeks
Change of serum creatinine
Time frame: 24 weeks
Change of fasting blood glucose
Time frame: 24 weeks
Change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Derived from this study: PubMed 34059026Sun F, Hong Y, Zhang H, Liu X, Zhao Z, He H, Yan Z, Zhu Z. Determination of adrenal hypersecretion in primary Aldosteronism without aldosterone-production adenomas. BMC Endocr Disord. 2021 May 31;21(1):114. doi: 10.1186/s12902-021-00770-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endovascular chemical Ablation of Adrenal Gland in people with Primary Aldosteronism and Hypertension, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 24-h average systolic blood pressure compared with the baseline (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03398785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.